Last updated: February 23, 2026
What is the drug associated with NDC 43598-0747?
NDC 43598-0747 refers to Tezspire (tezepelumab-ekko), a biologic monoclonal antibody approved by the FDA on December 17, 2021. It is indicated for severe asthma in adults and adolescents aged 12 and older, particularly in cases with eosinophilic phenotype or frequent exacerbations resistant to standard therapy.
What is the current market landscape?
The biologic asthma segment is highly competitive, dominated by drugs like:
- Nucala (mepolizumab)
- Cinqair (reslizumab)
- Fasenra (benralizumab)
- Dupixent (dupilumab)
Tezspire entered a market with established players, with total biologic asthma sales reaching approximately $8.5 billion in 2022 (EvaluatePharma). The drug's unique targeting of thymic stromal lymphopoietin (TSLP) positions it as a broad-spectrum biologic, potentially capturing unmet clinical needs in severe asthma management.
What is the current market size?
- The global severe asthma market was valued at $3 billion in 2022, with US sales accounting for approximately 60%.
- The biologic segment within asthma treatments is projected to grow at a compound annual growth rate (CAGR) of 9% through 2027.
- Tezspire's initial target market includes an estimated 300,000 eligible patients in the US, representing roughly 25% of the severe asthma population.
How does Tezspire compare with competitors?
| Parameter |
Tezspire |
Nucala |
Fasenra |
Cinqair |
Dupixent |
| FDA approval date |
2021 |
2015 |
2017 |
2016 |
2017 |
| Administration |
Monthly injection |
Monthly injection |
Monthly injection |
IV infusion every 4 weeks |
Biweekly injection |
| Efficacy indications |
Broad mechanism (upstream TSLP) |
Eosinophilic phenotype |
Eosinophilic phenotype |
Eosinophilic phenotype |
Eosinophilic, allergic, and atopic dermatitis |
| Pricing (per dose) |
~$4,000 |
~$4,000 |
~$3,300 |
~$2,900 |
~$3,500 |
Note: Pricing varies across payers and regions, with list prices ranging from $2,900 to $4,000 per dose.
What are the price projections?
- The drug's list price is stable at around $4,000 per dose.
- Assumed average patient treatment lasts for 12 months, with 12 injections annually.
- Payers and PBMs negotiate discounts, typically reducing net prices by 20-30%.
Short-term projections (2023-2025):
- List price remains around $4,000 per dose.
- Net price likely decreases to $2,800 - $3,200 after rebates.
- Market penetration expected to grow as provider familiarity increases; initial uptake is projected at 10-15% of eligible patients in 2023, rising to 25-35% by 2025.
Long-term projections (2026 onward):
- List price growth constrained to inflation + factor (~2-3% annually).
- Price sensitivity from payers may lead to continued rebates.
- Introduction of biosimilar-like competition is unlikely within the next 5 years due to the complexity of biologics.
What regulatory and reimbursement factors influence the price?
- CMS and private payer policies are key; AS comparable to other biologics, Tezspire's reimbursement will depend on formulary placement.
- Patient access programs are in place to mitigate high out-of-pocket costs.
- Off-label use and expansion: Beyond severe asthma—trials are underway for conditions like eosinophilic esophagitis, which may influence future pricing strategies.
What are the risks and uncertainties?
- Market penetration delays due to cautious provider adoption or competition.
- Pricing negotiations could limit revenue growth if payers push for deeper discounts.
- Clinical data indicating superior efficacy could justify premium pricing, but if data are comparable to existing therapies, price increases may be limited.
Summary of key data points
| Metric |
Value |
| Initial FDA approval date |
December 17, 2021 |
| US market size (2022) |
~$1.8 billion |
| Estimated patients (US) |
300,000 |
| List price per dose |
~$4,000 |
| Annual treatment cost |
~$48,000 |
| Market growth (2022-2027) |
9% CAGR |
| Expected market share (2025) |
25%–35% of eligible patients |
Key Takeaways
- Tezspire's entry intensifies the competitive landscape of biologics targeting severe asthma.
- Price stability at approximately $4,000 per dose is anticipated, with rebates and discounts affecting net revenues.
- Growth relies heavily on expanding indications, improving provider adoption, and payer acceptance.
- Long-term success depends on clinical differentiation and potential market expansion into other eosinophilic diseases.
- Risks include payer pushback on pricing and market saturation.
FAQs
1. How does Tezspire's pricing compare to other biologic asthma therapies?
It is similar in list price to Nucala and Fasenra, with rebates influencing net prices; the key differentiator is its mechanism and broad-spectrum efficacy.
2. What factors could influence cost savings for payers?
Reduced dosing frequency, improved clinical outcomes, and competition could lower effective costs through rebates and negotiated discounts.
3. Is there potential for price increases in the next five years?
Limited, unless clinical data support superior efficacy, or new indications expand the value proposition.
4. How does market penetration progress?
Expected to reach 15-20% of eligible patients in 2023, with growth to 25-35% by 2025 as awareness and provider familiarity increase.
5. What role might biosimilars play in this market?
High development cost and complex manufacturing make biosimilars unlikely within the next 5 years, maintaining premium pricing for biologics like Tezspire.
Citations:
[1] EvaluatePharma. (2023). Biologic asthma market sales data.
[2] FDA. (2021). FDA approval of Tezspire.
[3] IQVIA. (2022). Biologic medication forecast.
[4] Deloitte. (2022). Impact of payer strategies on biologic drug pricing.
